Infections contracted or acquired in hospitals and other health care facilities are the fourth largest killer of people in the United States. Each year in this country, almost two million patients contract infections in hospitals, and an estimated 103,000 of those patients die as a result. This number is as large as the combined totals of deaths from AIDS, breast cancer, and auto accidents. These deaths are largely due to respiratory system infections, urinary tract infections, catheter related infections, and surgical site infections resulting from accidental exposure to pathogens, breach of the duty or standard of care including carelessness or inattention by healthcare providers, failure to adhere to protocols, and/or deficient infection control procedures. The risk of urinary tract infection is known to be increased when catheterization of the urethra is required to remove urine from the bladder.
Conventional indwelling urinary catheters, which are used in approximately 20 percent of short-term care patients during their hospitalization or institutionalization, confer and present a predisposition to urinary tract infections. Catheter associated urinary tract infection (UTI) is the most common type of hospital-acquired infection, accounting for approximately 40 percent of such infections, and for most of the 900,000 patients with nosocomial bacteruria in United States hospitals and health care facilities each year. Adverse consequences associated with UTIs are significant and include local and systemic morbidity, secondary bloodstream infection, death, a reservoir of drug-resistant microorganisms, and increased health care costs.
It is generally accepted in this field that if a urinary catheter remains in place long enough, an infection is inevitable because, inter alia, biofilm formation typically occurs along the external and internal catheter surfaces. Host defenses have a difficult time preventing biofilm formation and the ascension of organisms into the bladder along the biofilm. The prevailing standard of care for the general treatment of urinary tract infections is the use of antibacterial drugs, including antibiotics. The length of treatment and choice of drug depend on the patient's medical history and the results of “mid-stream” urine tests that help identify the offending bacteria. The drugs most often and conventionally used to treat routine, uncomplicated urinary tract infections include trimethoprim sulfamethoxazole, nitrofurantoin, ampicillin, amoxicillin, ciprofloxacin, ofloxacin, norfloxacin, and trovafloxin.
In order to reduce the number of urinary tract infections caused by urinary catheterization, catheter manufacturers have developed antimicrobial coated or impregnated versions of the catheters. One known antibacterial catheter features a site-specific controlled release of nitrofurazone, which significantly reduces UTIs associated with catheter use. Nitrofurazone has been found to be effective against common gram-positive and gram-negative bacteria. This specialized coating is known to inhibit bacterial adherence and sustain the integrity of the urethral mucosa. Surprisingly, research has shown no clinically significant nitrofurazone resistance after over 50 years of use. Another conventional anti-microbial catheter uses a silver alloy coating and hydrogel. The occurrence of urinary tract infections has been found to be 3.7 times greater in patients catheterized with a standard catheter than in patients receiving catheters having the silver alloy coating and hydrogel. However, one disadvantage of antimicrobial catheters is that they can cost significantly more than the typical, conventional latex urinary catheter. As a result, clinicians and hospitals are reluctant to use them unless a sudden rise in the number of infections has occurred in the hospital or clinic, or if a drug resistant bacteria has been cultured from the patient or hospital or clinic.
There is a need in this art for a relatively inexpensive, simple to use device that can be used to inhibit bacterial growth and reduce biofilm formation on a urinary catheter near the opening to the urethra, be cost effective for all patients receiving a urinary catheter, be comfortable for the patient, and be gender specific. Such a device would provide the benefits of reducing the overall cost to the hospital or other healthcare provider and reducing the infection rate associated with UTIs, as well as providing a significant patient benefit.